This invention relates broadly to the art of urethral drainage catheters, and in particularly to such catheters as they may be used by males.
Voluntary control over discharge of bladder contents is a serious and distressing problem for persons whose natural anatomy is no longer capable of completely controlling the outflow of urine from the bladder for such reasons as advanced age, surgery, disease, trauma, denervation, or other malformation of the natural lower urinary tract.
Traditional urethral balloon catheters of a well-known type comprise a flexible tube which extends from outside the body along the urethra and into the bladder. The tube comprises a main lumen for passage of urine and a much smaller lumen leading to an annular expandable balloon, which is adjacent the distal end of the catheter and which can be expanded within the bladder by pumping a fluid along the smaller lumen to thereby prevent accidental retraction of the catheter. In such a system, urine is continuously drained through the main lumen into a bag which is worn by the patient. Alternately, in some embodiments, the main lumen, or tube, is clamped outside of the patients body and the patient removes the clamp to drain urine. This known type of balloon catheter, while serving its purpose, suffers from a number of disadvantages.
Many of the disadvantages arising from a drainage lumen extending outside of a body relate to retrograde spread of extracorporeal bacteria backing up into the lumen. Also, such an externally-extending lumen allows reflux of air into the bladder. The spread of bacterial along the urethra, bladder, and ultimately to the kidneys, can, of course, cause infections which can be potentially fatal. It is not thought necessary to catalog all of the ramifications of this problem here. With regard to reflux of air into the bladder, the air, acting as a desiccant, can initiate the precipitation of urate and other normally soluable urine components in the bladder which create undesirable crystalline deposits therein.
Other problems which are produced by the above-described known type of balloon catheter stem from its interference with a patient's normal bodily functions, such as bathing, locomotion and sex. This, in turn, reduces a patient's body image and encourages a negative self-concept.
Further, a patient can accidentally snag the externally extending tube on something, or agitated, demented, disoriented, and/or otherwise confused patients can pull on the externally extending tube voluntarily. Such stresses on the tube can be disastrous for a patient, especially if traumatic extirpation ensues which can cause frank hematuria, stricture formation, infection, prostatitis, impotence, etc. Further, such situations can arouse feelings of frustration, animonsity, and contempt in a patient or in medical staff members treating the patient.
U.S. Pat. No. 3,811,450 to Lord describes a catheter in which a drainage lumen extends only part way along the urethra, and therefore does not extend outside of a patient's body. However, in Lord's catheter there is a smaller tube for inflating a balloon and for removing the catheter extending out of the body. This smaller tube allows invasion of the body by bacteria and hampers normal body activity, such as sex. Also, Lord's catheter does not extend to the sphincter urethrae muscles, and requires those muscles to control urination. Thus, presumably, if those muscles are damaged. Lord's device cannot be used.
It is therefore an object of this invention to provide an indwelling urethral catheter which does not extend outside of the body but which is adequately held in position in the urethra. Also, it is an object of this invention to provide such a catheter which allows a patient to be continually continent while also controlling urination without necessarily requiring a functional lower urinary tract. Similarly, it is an object of this invention to provide structure for, and a method for, inserting such a catheter into a urethra.
Another difficulty with leading prior art urethral catheters is that external bags and tubes which must often be worn by patients using them, tend to emit an odor. In addition, often the patient cannot urinate at will as can most people, but must simply allow urine to drain into a bag. Both of these difficulties engender many of the psychological and physical problems which have already been set forth above. Therefore, it is another object of this invention to provide an indwelling urethral catheter which allows a patient to urinate at will so that urine is only expelled from the body under control of the patient with no external urine-contacting structures being necessary therefor.